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A Pilot Efficacy Study of Inhaled Albuterol Delivered With Akita Breath Control

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ClinicalTrials.gov Identifier: NCT00385359
Recruitment Status : Unknown
Verified October 2006 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : October 9, 2006
Last Update Posted : October 9, 2006
Sponsor:
Information provided by:
University Health Network, Toronto

Study Description
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Brief Summary:

Albuterol (salbutamol) is a widely used asthma medication but is associated with undesirable side effects such as shakiness and increased heart rate. Targeted delivery of albuterol to area of lungs where it has most effect would require a lower total dose to produce the same beneficial effects while reducing the side effects.

It is anticipated that only 1/13th to 1/25th of the standard nebulized dose of albuterol will be required to attain same bronchodilator response as a standard nebulizer treatment as determined by lung function measurement and that the reduced dose will significantly reduce side effects as determined by hand tremor and heart rate.


Condition or disease Intervention/treatment Phase
Asthma Procedure: aerosol drug deposition strategies Drug: Albuterol Phase 4

Detailed Description:

Side effects of albuterol (salbutamol)are directly related to the dose delivered and absorbed into blood stream. By controlling aerosol delivery, dose delivered, site of deposition, amount of drug absorption can be determined and thus the magnitude of the side effects. Delivery and deposition of aerosols are determined by both aerosol characteristics (size and timing of delivery) and breathing characteristics (breath size, flow rate and breathholding). Data supports the theory that if a high dose of albuterol can be deposited in the larger airway generations and prevented from entering the pulmonary circulation from the lung periphery, that this will result in the largest magnitude of bronchodilator response with the lowest circulatory absorbance.

This is a pilot study in 10 adults with moderate asthma. there are no investigational drugs or devices. It is an investigation of a strategy to maximize response to an approved drug while minimizing side effects. The investigational strategies will deposit less than 25% of the standard nebulized dose in the airways. This will be accomplished by pairing a Pari eFlow nebulizer configured to deliver particle sizes of 3.5 to 6 microns, with an Akita delivery system programmed to deliver the drug as either a late or early bolus during inspiration. The Akita is programmed with a specific breathing pattern based on participant's lung function tests at screening.

Moderate asthmatics with bronchodilator response >20% improvement in FEV1 will be selected. Treatments will be administered on separate days 1-7 days apart. Following baseline measurements 1 of 5 randomized aerosol treatments will be administered. Efficacy (FEV1) and side effects (tremor and heart rate)will be monitored for 6 hours following drug administration.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Efficacy Study of Inhaled Albuterol Delivered With Akita Breath Control and Pari Nebulization for the Treatment of Adults With Moderate Asthma
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. change in FEV1 expressed as a percent of predicted between baseline and 1 hour post drug administration.

Secondary Outcome Measures :
  1. duration of effect based on FEV1 at 6 hours post treatment compared to standard treatment
  2. change in hand tremor compared to standard treatment
  3. change in heart rate compared to standard treatment

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 18-60 years
  • Moderate asthma with baseline FEV1 40-75% predicted
  • Previous use of albuterol (salbutamol)
  • At least 20% improvement in FEV1 following 2.5 mg albuterol (salbutamol) delivered by nebulizer
  • O2 saturation > 90%
  • Non-smoker for > 6 months

Exclusion Criteria:

  • Upper respiratory tract infection or asthma exacerbation within 14 days of screening
  • Clinically significant abnormal chest radiograph
  • History of cardiovascular disorder including coronary insufficiency, cardiac arrhythmias or hypertension
  • Unable to tolerate bronchodilator withdrawal
  • Known hypersensitivity to albuterol (salbutamol)
  • Change in asthma treatment regimen in past 30 days
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385359


Contacts
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Contact: Patricia McClean, MSc 416-603-5800 ext 3438 pmcclean@uhnres.utoronto.ca
Contact: Pearl Latty, BSc 416-603-5489 platty@uhnres.utoronto.ca

Locations
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Canada, Ontario
Toronto Western Hospital - Respiratory Research Lab Recruiting
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Victor Hoffstein, MD University Health Network, Toronto
More Information
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ClinicalTrials.gov Identifier: NCT00385359    
Other Study ID Numbers: IA-01
First Posted: October 9, 2006    Key Record Dates
Last Update Posted: October 9, 2006
Last Verified: October 2006
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action